MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE IMPULSE GUIDE CATHETERS; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number UNK189

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-07604 and 2134265-2016-08428.It was reported a perforation occurred resulting in pericardial effusion with tamponade.A left atrial appendage (laa) closure procedure was being performed.During the sheath exchange, it was noted that the amplatz super stiff guidewire was in the laa briefly.The wire was removed and they exchanged the sheath for the watchman access system (was).They had an impulse pigtail catheter within the was in the laa contrast was injected.The pigtail was removed and they were preparing to insert the watchman laa closure device and delivery system into the was; however, they were not getting good blood return on the was, so they pulled it back.They then noticed that the patient's blood pressure dropped and a pericardial effusion with tamponade was noted.Pericardiocentesis was performed.The patient was stabilized and taken to the intensive care unit.The patient became unstable again, so they performed surgery to repair the laceration to the laa and the left ventricle which was believed to have occurred during the pericardiocentesis.The patient is currently doing well and another laa closure procedure will be scheduled for a future time as the laa was not closed during surgery.

• Brand Name: IMPULSE GUIDE CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5923381
• MDR Text Key: 53781300
• Report Number: 2134265-2016-08429
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2016
• Initial Date FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR